Abstract
Background: Acute kidney injury (AKI) is associated with poor outcome in critically ill children. While data extracted from retrospective study of pediatric populations demonstrate a high incidence of AKI, the literature lacks focused and comprehensive multicenter studies describing AKI risk factors, epidemiology, and outcome. Additionally, very few pediatric studies have examined novel urinary biomarkers outside of the cardiopulmonary bypass population. Methods/Design: This is a prospective observational study. We anticipate collecting data on over 5000 critically ill children admitted to 31 pediatric intensive care units (PICUs) across the world during the calendar year of 2014. Data will be collected for seven days on all children older than 90 days and younger than 25 years without baseline stage 5 chronic kidney disease, chronic renal replacement therapy, and outside of 90 days of a kidney transplant or from surgical correction of congenital heart disease. Data to be collected includes demographic information, admission diagnoses and co-morbidities, and details on fluid and vasoactive resuscitation used. The renal angina index will be calculated integrating risk factors and early changes in serum creatinine and fluid overload. On days 2-7, all hemodynamic and pertinent laboratory values will be captured focusing on AKI pertinent values. Daily calculated values will include % fluid overload, fluid corrected creatinine, and KDIGO AKI stage. Urine will be captured twice daily for biomarker analysis on Days 0-3 of admission. Biomarkers to be measured include neutrophil gelatinase lipocalin (NGAL), kidney injury molecule-1 (KIM-1), liver-type fatty acid binding protein (l-FABP), and interleukin-18 (IL-18). The primary outcome to be quantified is incidence rate of severe AKI on Day 3 (Day 3 - AKI). Prediction of Day 3 - AKI by the RAI and after incorporation of biomarkers with RAI will be analyzed. Discussion: The Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology (AWARE) study, creates the first prospective international pediatric all cause AKI data warehouse and biologic sample repository, providing a broad and invaluable resource for critical care nephrologists seeking to study risk factors, prediction, identification, and treatment options for a disease syndrome with high associated morbidity affecting a significant proportion of hospitalized children. Trial registration: ClinicalTrials.gov:
| Original language | English (US) |
|---|---|
| Article number | 24 |
| Journal | BMC nephrology |
| Volume | 16 |
| Issue number | 1 |
| DOIs | |
| State | Published - Dec 1 2015 |
Funding
AWARE is sponsored by the Center for Acute Care Nephrology at Cincinnati Childrens Hospital Medical Center. The investigators appreciate the Cincinnati Children’s Hospital Research Foundation’s financial support for the development of the AWARE database platform. This work was supported in part by a grant from the NIH (P50 DK096418). Biomarker measurements were performed in the lab of Prasad Devarajan MD, principal investigator of the Cincinnati Children’s Hospital Nephrology Center for Excellence. The authors would like to thank the site investigators and coordinators for their work on the trial. University of Alabama Birmingham, David Askenazi; Children’s Hospital Colorado, Katja Gist; Lucille Packard Children’s Hospital of Stanford University, Scott Sutherland; Yale University, Olja Couloures, Vince Faustino; Nemours/Alfred l. DuPont Hospital for Children, Joshua Zaritksy; Children’s Healthcare of Atlanta of Emory University, Matthew Paden; University of Iowa, Patrick Brophy; C.S. Mott Children’s Hospital of the University of Michigan, David Selewski; Helen DeVos Children’s Hospital of Grand Rapids, Richard Hackbarth; Children’s Mercy Hospital and Clinics, Vimal Chadha; Washington University of St. Louis Children’s Hospital, Vikas Dharnidharka, Thomas Davis; University of New Mexico, Craig Wong; Cohen Children’s Medical Center of New York, James Schneider; Columbia University Medical Center, Fangming Lin; Stony Brook Long Island Children’s Hospital, Robert Woroniecki; Vanderbilt University, Geoffrey Fleming; Texas Children’s Hospital, Alyssa Riley, Ayse Arikan; Virginia Commonwealth University, Timothy Bunchman, Duane Williams; The Sydney Children’s Hospitals Network - Randwick, Stephen Alexander, Sean Kennedy; The Sydney Children’s Hospitals Network – Westmead, Dierdre Hahn; University of Edmonton, Catherine Morgan; Montreal Children’s Hospital of McGill University, Michael Zappitelli, Ana Peljian; University of British Columbia and Children’s and Women’s Health Center, Cherry Mammen; Nanjing Children’s Hospital, Nanjing, China, Songming Huang; Department of Child Health Cipto Mangunkusumo of the University of Indonesia, Eka Hidayati; Department of Child Health Airlangga University/Dr. Soetomo Hospital, Surbaya, Indonesia, Risky Prasetyo, Noer Soemyarso; Ospedale Pediatrico Bambino Gesu, Rome, Italy, Stephano Picca; Seoul National University Children’s Hospital, Seoul, Republic of Korea, Il-Soo Ha, Hee Gyung Kang; King’s College Hospital, London, United Kingdom, Akash Deep.; Institute for Mother and Child Health Care, Belgrade, Serbia, Natasa Stajic; University Children’s Hospital Belgrade, Belgrade, Serbia, Brankica Spasojevic.
Keywords
- Acute kidney injury
- Critical care
- Pediatrics
- Renal angina
ASJC Scopus subject areas
- Nephrology